Bellicum Pharmaceuticals Announces Initiation of Phase I/II Clinical Trial of Novel Vaccine for Patients With Advanced Prost...( HOUSTON Aug. 6 /- B...),Health

HOUSTON, Aug. 6 /PRNewswire/ -- Bellicum Pharmaceuticals, Inc. today announced dosing of the first patient in a Phase I/II clinical trial of BP-GMAX-CD1, a novel pharmacologically regulated dendritic cell vaccine for the treatment of prostate cancer. The disease-specific trial is being conducted under a Bellicum Investigational New Drug application allowed by the FDA in 2008. The company anticipates reporting initial results of the study in 2010.

BP-GMAX-CD1 is a novel cancer vaccine that can be precisely activated at an optimal time and location in the body. It is produced by genetically modifying autologous antigen-loaded dendritic cells to express an inducible costimulatory CD40 (iCD40) receptor. Twenty-four hours after intradermal administration, these genetically modified dendritic cells are activated in draining lymph nodes by intravenous administration of AP1903, a small-molecule dimerizer agent developed by ARIAD Pharmaceuticals, Inc. (Nasdaq: ARIA). In this way, the immune system's innate homeostasis is overridden and a potent and durable antigen-specific T cell response may be generated.

The dose-escalation trial will evaluate the safety of BP-GMAX-CD1 and AP1903 in a minimum of 24 patients with androgen independent prostate cancer (also known as castrate resistant prostate cancer or CRPC). Six doses will be administered on a weekly or every other week schedule, with responses assessed at week 13. Patients whose disease has not progressed at the end of this acute phase will be eligible to receive booster vaccinations every eight weeks for up to one year. Exploratory efficacy endpoints include prostate-specific antigen dynamics, circulating tumor cell count, antigen-specific immune response, and clinical response. Additional information can be found at www.clinicaltrials.gov.

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